ZOCOR TABLETS 10MG

Transcript

386-387 LEAFLET Zocor 20130411.doc

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOCOR 10mg TABLETS
ZOCOR 20mg TABLETS
(simvastatin)
Your medicine is known as Zocor 10mg Tablets but will be referred
to as Zocor throughout the following leaflet.
Information for other strength of Zocor also may be present in this
leaflet.



Tell your doctor if you have ever had liver disease. Zocor may
not be right for you.



Tell your doctor if you are due to have an operation. You may
need to stop taking Zocor tablets for a short time.



Your doctor should do a blood test before you start taking Zocor
and if you have any symptoms of liver problems while you take
Zocor. This is to check how well your liver is working.



Your doctor may also want you to have blood tests to check
how well your liver is working after you start taking Zocor.



While you are on this medicine your doctor will monitor you
closely if you have diabetes or are at risk of developing
diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.

Read all of this leaflet carefully before you start taking this
medicine.
-

Keep this leaflet. You may need to read it again.

-

If you have any further questions, ask your doctor or
pharmacist.

-

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

-

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

 Tell your doctor if you have severe lung disease.
Contact your doctor immediately if you experience
unexplained muscle pain, tenderness, or weakness. This is
because on rare occasions, muscle problems can be serious,
including muscle breakdown resulting in kidney damage; and
very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of Zocor,
particularly the 80-mg dose. The risk of muscle breakdown is
greater in certain patients. Talk with your doctor if any of the
following applies:

In this leaflet:



you consume large amounts of alcohol

1. What Zocor is and what it is used for



you have kidney problems

2. Before you take Zocor



you have thyroid problems

3. How to take Zocor



you are 65 years or older



you are female



you have ever had muscle problems during treatment with
cholesterol-lowering medicines called “statins” or fibrates



you or a close family member have a hereditary muscle
disorder.

4. Possible side effects
5. How to store Zocor
6. Further information
1. WHAT ZOCOR IS AND WHAT IT IS USED FOR
Zocor is a medicine used to lower levels of total cholesterol, “bad”
cholesterol (LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition, Zocor raises levels of “good”
cholesterol (HDL cholesterol). You should stay on a cholesterollowering diet while taking this medicine. Zocor is a member of the
class of drugs called statins.

HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (medicines for AIDS)



boceprevir or telaprevir (medicines for hepatitis C virus
infection)

In most people, there are no immediate symptoms of high
cholesterol. Your doctor can measure your cholesterol with a simple
blood test. Visit your doctor regularly, keep track of your cholesterol,
and discuss your goals with your doctor.



nefazodone (a medicine for depression)



amiodarone (a medicine for an irregular heartbeat)



2. BEFORE YOU TAKE ZOCOR

verapamil, diltiazem or amlodipine (medicines for high blood
pressure, chest pain associated with heart disease, or other
heart conditions)

a hereditary illness (homozygous familial
hypercholesterolaemia) that increases the cholesterol level in
your blood. You may also receive other treatments.



coronary heart disease (CHD) or are at high risk of CHD
(because you have diabetes, history of stroke, or other blood
vessel disease). Zocor may prolong your life by reducing the
risk of heart disease problems, regardless of the amount of
cholesterol in your blood.

Do not take Zocor

It is particularly important to tell your doctor if you are taking any of
the following drugs. Taking Zocor with any of these drugs can
increase the risk of muscle problems (some of these have already
been listed in the above section “Do not take Zocor”).



if you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of Zocor Tablets (see Section 6: Further
Information).

As well as the medicines listed above, tell your doctor or pharmacist
if you are taking or have recently taken any other medicines,
including those obtained without a prescription. In particular, tell
your doctor if you are taking any of the following:



if you currently have liver problems





if you are pregnant or breast‑feeding

medicines to prevent blood clots, such as warfarin,
phenprocoumon or acenocoumarol (anticoagulants)



if you are taking one or more than one of the following drugs at
the same time:

HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, and saquinavir (HIV protease inhibitors are used
for HIV infections)

o

boceprevir or telaprevir (medicines for hepatitis C virus
infection)

o

nefazodone (a medicine for depression)

o

gemfibrozil (a medicine for lowering cholesterol)

o

ciclosporin (a medicine often used in organ transplant
patients)

o

danazol (a man-made hormone used to treat
endometriosis).

Also tell your doctor if you are taking niacin (nicotinic acid) or a
niacin-containing product and are Chinese.

Ask your doctor if you are not sure if your medicine is listed
above.
Take special care with Zocor


Tell your doctor about all your medical conditions including
allergies.



Tell your doctor if you drink large amounts of alcohol.

You should also tell any doctor who is prescribing a new medicine
for you that you are taking Zocor.
Taking Zocor with food and drink
Grapefruit juice contains one or more components that alter how
the body uses some medicinal products, including Zocor.
Consuming grapefruit juice should be avoided.
Pregnancy and Breast-feeding
Do not take Zocor if you are pregnant, trying to get pregnant or
think you may be pregnant. If you get pregnant while taking Zocor,
stop taking it immediately and contact your doctor. Do not take
Zocor if you are breast-feeding, because it is not known if the
medicine is passed into breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine.

Children



Safety and effectiveness have been studied in 10-17 year old boys
and in girls who had started their menstrual period at least one year
before (see HOW TO TAKE ZOCOR). Zocor has not been studied
in children under the age of 10 years. For more information, talk to
your doctor.
Driving and using machines

inflammation of the liver with the following symptoms: yellowing
of the skin and eyes, itching, dark-coloured urine or palecoloured stool, feeling tired or weak, loss of appetite; liver
failure (very rare)

Zocor is not expected to interfere with your ability to drive or to use
machinery. However, it should be taken into account that some
people get dizzy after taking Zocor.

poor memory (very rare), memory loss, confusion.

Important information about some of the ingredients of Zocor
Zocor tablets contain a sugar called lactose. If you have been told
by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE ZOCOR
Always take Zocor exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

The following side effects have also been reported but the
frequency cannot be estimated from the available information
(frequency not known):

You should stay on a cholesterol-lowering diet while taking Zocor.



erectile dysfunction

The dose is 1 Zocor 10 mg, 20 mg, 40 mg, or 80 mg tablet by
mouth once a day.



depression



inflammation of the lungs causing breathing problems including
persistent cough and/or shortness of breath or fever



tendon problems, sometimes complicated by rupture of the
tendon.

For children (10-17 years old), the recommended usual starting
dose is 10 mg a day in the evening. The maximum recommended
dose is 40 mg a day.
The 80 mg dose is only recommended for adult patients with very
high cholesterol levels and at high risk of heart disease problems
who have not reached their cholesterol goal on lower doses.
Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your
personal risk status.
Take Zocor in the evening. You can take it with or without food. The
usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your
doctor may adjust your dose after at least 4 weeks to a maximum of
80 mg a day. Do not take more than 80 mg a day. Your doctor may
prescribe lower doses, particularly if you are taking certain
medicinal products listed above or have certain kidney conditions.
Keep taking Zocor unless your doctor tells you to stop.
If your doctor has prescribed Zocor along with any bile acid
sequestrant (medicines for lowering cholesterol), you should take
Zocor at least 2 hours before or 4 hours after taking the bile acid
sequestrant.

Additional possible side effects reported with some statins:


sleep disturbances, including nightmares



sexual difficulties



diabetes. This is more likely if you have high levels of sugars
and fats in your blood, are overweight and have high blood
pressure. Your doctor will monitor you while you are taking this
medicine.

Laboratory Values
Elevations in some laboratory blood tests of liver function and a
muscle enzyme (creatine kinase) have been observed.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZOCOR
Do not store above 25°C. Store in the original container.



Do not use Zocor after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





If you take more Zocor than you should



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

please contact your doctor or pharmacist.

If you forget to take Zocor


do not take an extra dose, just take your normal amount of
Zocor at the usual time the next day.

If you stop taking Zocor


your cholesterol may rise again.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Rare (occurring in 1 or more of 10,000 and less than 1 of 1000
patients treated)



Very rare (occurring in less than 1 of 10,000 patients treated).



Frequency not known

The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking the
medicine and tell your doctor immediately or go to the
emergency room at your nearest hospital.


muscle pain, tenderness, weakness, or cramps. On rare
occasions, these muscle problems can be serious, including
muscle breakdown resulting in kidney damage; and very rare
deaths have occurred.



hypersensitivity (allergic) reactions including:

What Zocor looks like and contents of the pack
Zocor Tablets 10mg are small, round, biconvex, peach-coloured,
film-coated tablets marked ‘10’ on one side and with a breakline on
the other.
Zocor Tablets 20mg are round, biconvex, tan-coloured, film-coated
tablets marked ‘20’ on one side.
Zocor is available as blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



swelling of the face, tongue and throat which may cause
difficulty in breathing

Tell your doctor if you have ever had liver disease. Simvastatin
Tablet may not be right for you.



Tell your doctor if you are due to have an operation. You may
need to stop taking Simvastatin Tablet tablets for a short time.



Information for other strength of Simvastatin Tablet also may be
present in this leaflet.

Your doctor should do a blood test before you start taking
Simvastatin Tablet and if you have any symptoms of liver
problems while you take Simvastatin Tablet. This is to check
how well your liver is working.



Read all of this leaflet carefully before you start taking this
medicine.

Your doctor may also want you to have blood tests to check
how well your liver is working after you start taking Simvastatin
Tablet.



While you are on this medicine your doctor will monitor you
closely if you have diabetes or are at risk of developing
diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.



Tell your doctor if you have severe lung disease.

386-387 LEAFLET Simvastatin 20130411.doc

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN 10mg TABLETS
SIMVASTATIN 20mg TABLETS
Your medicine is known by either of the above names but will be
referred to as Simvastatin Tablet throughout the following leaflet.

-

Keep this leaflet. You may need to read it again.

-

If you have any further questions, ask your doctor or
pharmacist.

-

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

-

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Simvastatin Tablet is and what it is used for
2. Before you take Simvastatin Tablet
3. How to take Simvastatin Tablet
4. Possible side effects
5. How to store Simvastatin Tablet
6. Further information
1. WHAT SIMVASTATIN TABLET IS AND WHAT IT IS USED
FOR
Simvastatin Tablet is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the blood. In addition, Simvastatin
Tablet raises levels of “good” cholesterol (HDL cholesterol). You
should stay on a cholesterol-lowering diet while taking this
medicine. Simvastatin Tablet is a member of the class of drugs
called statins.

Contact your doctor immediately if you experience
unexplained muscle pain, tenderness, or weakness. This is
because on rare occasions, muscle problems can be serious,
including muscle breakdown resulting in kidney damage; and
very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of
Simvastatin Tablet, particularly the 80-mg dose. The risk of muscle
breakdown is greater in certain patients. Talk with your doctor if any
of the following applies:


you consume large amounts of alcohol



you have kidney problems



you have thyroid problems



you are 65 years or older



you are female



you have ever had muscle problems during treatment with
cholesterol-lowering medicines called “statins” or fibrates



you or a close family member have a hereditary muscle
disorder.

Using other medicines

Simvastatin Tablet is used along with diet if you have:

It is particularly important to tell your doctor if you are taking any of
the following drugs. Taking Simvastatin Tablet with any of these
drugs can increase the risk of muscle problems (some of these
have already been listed in the above section “Do not take
Simvastatin Tablet”).

HIV protease inhibitors such as indinavir, nelfinavir, ritonavir,
and saquinavir (medicines for AIDS)



boceprevir or telaprevir (medicines for hepatitis C virus
infection)



nefazodone (a medicine for depression)



amiodarone (a medicine for an irregular heartbeat)



verapamil, diltiazem or amlodipine (medicines for high blood
pressure, chest pain associated with heart disease, or other
heart conditions)



colchicine (a medicine used to treat gout).





a raised cholesterol level in your blood (primary
hypercholesterolaemia) or elevated fat levels in your blood
(mixed hyperlipidaemia)
a hereditary illness (homozygous familial
hypercholesterolaemia) that increases the cholesterol level in
your blood. You may also receive other treatments.
coronary heart disease (CHD) or are at high risk of CHD
(because you have diabetes, history of stroke, or other blood
vessel disease). Simvastatin Tablet may prolong your life by
reducing the risk of heart disease problems, regardless of the
amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high
cholesterol. Your doctor can measure your cholesterol with a simple
blood test. Visit your doctor regularly, keep track of your cholesterol,
and discuss your goals with your doctor.
2. BEFORE YOU TAKE SIMVASTATIN TABLET
Do not take Simvastatin Tablet


if you are allergic (hypersensitive) to simvastatin or any of the
other ingredients of Simvastatin Tablets (see Section 6: Further
Information).



if you currently have liver problems



if you are pregnant or breast‑feeding



if you are taking one or more than one of the following drugs at
the same time:
o
o
o

itraconazole, ketoconazole, or posaconazole (medicines for
fungal infections)
erythromycin, clarithromycin, or telithromycin (antibiotics for
infections)
HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir, and saquinavir (HIV protease inhibitors are used
for HIV infections)

o

boceprevir or telaprevir (medicines for hepatitis C virus
infection)

o

nefazodone (a medicine for depression)

o

gemfibrozil (a medicine for lowering cholesterol)

o

ciclosporin (a medicine often used in organ transplant
patients)

o

danazol (a man-made hormone used to treat
endometriosis).

Ask your doctor if you are not sure if your medicine is listed
above.
Take special care with Simvastatin Tablet


Tell your doctor about all your medical conditions including
allergies.



Tell your doctor if you drink large amounts of alcohol.

As well as the medicines listed above, tell your doctor or pharmacist
if you are taking or have recently taken any other medicines,
including those obtained without a prescription. In particular, tell
your doctor if you are taking any of the following:


medicines to prevent blood clots, such as warfarin,
phenprocoumon or acenocoumarol (anticoagulants)



fenofibrate (another medicine for lowering cholesterol)



niacin (another medicine for lowering cholesterol)



rifampicin (a medicine used to treat tuberculosis).

Also tell your doctor if you are taking niacin (nicotinic acid) or a
niacin-containing product and are Chinese.
You should also tell any doctor who is prescribing a new medicine
for you that you are taking Simvastatin Tablet.
Taking Simvastatin Tablet with food and drink
Grapefruit juice contains one or more components that alter how
the body uses some medicinal products, including Simvastatin
Tablet. Consuming grapefruit juice should be avoided.
Pregnancy and Breast-feeding
Do not take Simvastatin Tablet if you are pregnant, trying to get
pregnant or think you may be pregnant. If you get pregnant while
taking Simvastatin Tablet, stop taking it immediately and contact
your doctor. Do not take Simvastatin Tablet if you are breastfeeding, because it is not known if the medicine is passed into
breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine.

Children



Safety and effectiveness have been studied in 10-17 year old boys
and in girls who had started their menstrual period at least one year
before (see HOW TO TAKE SIMVASTATIN TABLET). Simvastatin
Tablet has not been studied in children under the age of 10 years.
For more information, talk to your doctor.
Driving and using machines

inflammation of the liver with the following symptoms: yellowing
of the skin and eyes, itching, dark-coloured urine or palecoloured stool, feeling tired or weak, loss of appetite; liver
failure (very rare)



inflammation of the pancreas often with severe abdominal pain.

The following side effects have also been reported rarely:


low red blood cell count (anaemia)

Simvastatin Tablet is not expected to interfere with your ability to
drive or to use machinery. However, it should be taken into account
that some people get dizzy after taking Simvastatin Tablet.



numbness or weakness of the arms and legs



headache, tingling sensation, dizziness

Important information about some of the ingredients of
Simvastatin Tablet

Simvastatin Tablet tablets contain a sugar called lactose. If you
have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.



rash, itching, hair loss



weakness



trouble sleeping (very rare)



poor memory (very rare), memory loss, confusion.

3. HOW TO TAKE SIMVASTATIN TABLET
Always take Simvastatin Tablet exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
You should stay on a cholesterol-lowering diet while taking
Simvastatin Tablet.
The dose is 1 Simvastatin Tablet 10 mg, 20 mg, 40 mg, or 80 mg
tablet by mouth once a day.
For children (10-17 years old), the recommended usual starting
dose is 10 mg a day in the evening. The maximum recommended
dose is 40 mg a day.
The 80 mg dose is only recommended for adult patients with very
high cholesterol levels and at high risk of heart disease problems
who have not reached their cholesterol goal on lower doses.
Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your
personal risk status.
Take Simvastatin Tablet in the evening. You can take it with or
without food. The usual starting dose is 10, 20 or, in some cases,
40 mg a day. Your doctor may adjust your dose after at least 4
weeks to a maximum of 80 mg a day. Do not take more than 80 mg
a day. Your doctor may prescribe lower doses, particularly if you
are taking certain medicinal products listed above or have certain
kidney conditions. Keep taking Simvastatin Tablet unless your
doctor tells you to stop.
If your doctor has prescribed Simvastatin Tablet along with any bile
acid sequestrant (medicines for lowering cholesterol), you should
take Simvastatin Tablet at least 2 hours before or 4 hours after
taking the bile acid sequestrant.

The following side effects have also been reported but the
frequency cannot be estimated from the available information
(frequency not known):


erectile dysfunction



depression



inflammation of the lungs causing breathing problems including
persistent cough and/or shortness of breath or fever.



tendon problems, sometimes complicated by rupture of the
tendon.

Additional possible side effects reported with some statins:


sleep disturbances, including nightmares



sexual difficulties



diabetes. This is more likely if you have high levels of sugars
and fats in your blood, are overweight and have high blood
pressure. Your doctor will monitor you while you are taking this
medicine.

Laboratory Values
Elevations in some laboratory blood tests of liver function and a
muscle enzyme (creatine kinase) have been observed.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SIMVASTATIN TABLET


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the original container.



Do not use Simvastatin Tablet after the expiry date which is
stated on the carton and blister strip. The expiry date refers to
the last day of that month.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you take more Simvastatin Tablet than you should


please contact your doctor or pharmacist.

If you forget to take Simvastatin Tablet


do not take an extra dose, just take your normal amount of
Simvastatin Tablet at the usual time the next day.

If you stop taking Simvastatin Tablet


your cholesterol may rise again.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin Tablet can cause side effects,
although not everybody gets them.
The following terms are used to describe how often side effects
have been reported:


Rare (occurring in 1 or more of 10,000 and less than 1 of 1000
patients treated)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.